Lead Medical Device Software Architect

5 days ago

Islamabad, Islamabad, Pakistan beBeeSoftware Full time 9,000,000 - 12,000,000
Senior Full Stack Developer / Architect Job Description

This is a unique and challenging position that requires a lead programmer who is obsessed with product and company success. We are offering competitive starting pay with the opportunity for major incentives/raises/bonuses.

The core product is programmed in SWIFT and runs on an iPad Pro 11-inch tablet using the Apple Pencil 2 Stylus. Our backend uses a combination of EC2 instances with Django, Gunicorn, and Nginx; AWS cloud, Amazon RDS (PostgreSQL), S3 and Amazon CloudFront, and Heroku.

We also utilize an admin panel website and various API/SDK's from 3rd party apps and unrestricted open-source code.

Key Responsibilities:
  • Transition and transform current software prototype: Lead transition process from old software team to you and your team. Assist in creation of a small team of 2-3 core programmers.
  • Manage Software Development Life Cycle (SDLC): Drive all stages of the SDLC, ensuring our medical device software aligns with FDA guidelines & IEC 62304 from prototype to deployment and maintenance.
  • Architecture and programming: Pragmatically develop and improve software architecture by weighing pros and cons with options.
  • Team management: Lead our programming team and communicate with CEO when additional people are required full time or for specific contracted roles.
  • Regulatory learning: It is likely that the applicant will not have experience in all required regulatory areas. As such, it will be mandatory for candidate to learn these regulations alongside the CEO and regulatory expert on the team.
  • Risk management: Implement an effective risk management process that identifies and mitigates potential hazards throughout the software's lifecycle, in alignment with ISO 14971 standards.
  • Quality Management: Establish a robust Quality Management System (QMS) per FDA's Quality System Regulation (QSR) and ISO 13485.
  • Validation and Verification (V&V) leadership: Direct and perform V&V activities ensuring that the software/device meet user needs, intended uses, and consistently fulfills all requirements.
  • Design control procedures: Implement design controls in compliance with FDA regulations.
  • Cybersecurity governance: Address potential vulnerabilities, strategize, and oversee cybersecurity in compliance with FDA guidelines.
  • Data integrity and security: Ensure robust data integrity, security, and compliance with laws like HIPAA and GDPR.
Required Skills and Qualifications

Full stack programming background required. Clear experience and success in senior programming roles required. Prior experience in medical software and/or devices is recommended but not required.

Familiarity with regulatory standards is beneficial, but the ability to learn and apply these regulations is also acceptable as guidance will be provided.

Benefits

Competitive starting pay with the opportunity for major incentives/raises/bonuses. Expectations are high and the selected candidate will be responsible for leading the programming department and learning/applying new skills specific to this position.

Others

Job Type: Full-time

Application Question(s): Please describe your greatest accomplishment. Please provide any metrics that would be useful in understanding your credentials.

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